clarithromycin

Product NDC
67296-1072
11-digit product format
672961072
Labeler code
67296
Product ID
67296-1072_d60fb249-4bff-52a6-e053-2995a90a54ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065145
Marketing category
ANDA
Marketing start
2008-01-01
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1072-12024-01-30C16284748780-11030e365-02bb-111a-e063-dadaa90a10e24e79245f-ecfd-04c4-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1072-1clarithromycin14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1072CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220121_4e79245f-ecfd-04c4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSN4e79245f-ecfd-04c4-e054-00144ff88e883
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCD4e79245f-ecfd-04c4-e054-00144ff88e883
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSY4e79245f-ecfd-04c4-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1072-16729610720114 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67296-1072-1) 2008-01-010000-00-00NoNoCurrent